A Feasibility Study for Randomization of Code Stroke Imaging Strategies

NCT06270927 | Active Not Recruiting

• 1 other identifier: 00003830
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to test feasibility of a comparative effectiveness framework for acute stroke imaging using prospective electronic health data. This is a prospective, cohort feasibility study of patients presenting to the Emergency Department with suspected acute ischemic stroke. The clinical stroke team will not be blinded to the imaging modality given the nature and purpose of the interventions/imaging. Knowledge of the imaging modality used and the knowledge gained from the resulting data will need to be considered for treatment decisions. Blinding will be maintained for data abstraction and analyses. Analysis will be on an "intent-to-scan" basis and all qualifying patients will be included in their assigned cohort.

Conditions

Brain Ischemia

Keywords

Stroke; Neuroimaging

Outcome Measures

Primary Outcomes (1)

• compliance

  adherence to assigned first-scan imaging modality quantified as number of cross-overs (i.e., MRI scheduled but CT performed) relative to the sample size.

  Two phases will be included. Phase A: 12 weeks of cluster randomization with the initiation of each site staggered by 1 week, for a total of 15 weeks Phase B: 5 weeks of per-patient randomization Total time for enrollment: 20 weeks

Study Arms (2)

MRI

patients assigned to MRI

Diagnostic Test: MRI; Diagnostic Test: CT

CT

patients assigned to CT

Diagnostic Test: MRI; Diagnostic Test: CT

Interventions

MRI DIAGNOSTIC_TEST

neuroimaging using MRI scanner

Also known as: magnetic resonance imaging

CT; MRI

CT DIAGNOSTIC_TEST

neuroimaging using CT scanner

Also known as: computed tomography

CT; MRI

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients presenting as Code Stroke to Emergency Department at one of four network stroke centers

You may qualify if:

• Age ≥ 18 years
• Time last known well to presentation ≤ 24 hours
• Code-stroke (suspected treatable ischemic stroke) called prior to or upon arrival to Emergency Department
• Presenting to Emergency Department for first time during study period

You may not qualify if:

• Transfer patients
• Contraindication for brain perfusion scan

Sponsors & Collaborators

• Ascension Texas: collaborator
• University of Texas at Austin: lead
• Lone Star Stroke Research Consortium: collaborator

Study Sites (1)

Ascension Seton

Austin, Texas, 78712, United States

Location

MeSH Terms

Conditions

Brain Ischemia; Stroke

Interventions

Magnetic Resonance Imaging; Tomography, X-Ray Computed

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Image Interpretation, Computer-Assisted; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Neurology

Study Record Dates

• First Submitted: January 12, 2024
• First Posted: February 21, 2024
• Study Start: October 23, 2023
• Primary Completion: December 30, 2025
• Study Completion (Estimated): May 31, 2026
• Last Updated: May 1, 2026

Record last verified: 2026-04

Locations

US (1)